In recent years, steerable catheters have been developed to combat the effects of the dynamic cardiac environment. Mechanically actuated steerable catheters appear the most in the clinical setting; however, they are bound to a number of mechanical limitations. The aim of this research is to gain insight in these limitations and use this information to develop a new prototype of a catheter with increased steerability. The main limitations in mechanically steerable catheters are identified and analysed, after which requirements and solutions are defined to design a multi-steerable catheter. Finally, a prototype is built and a proof-of-concept test is carried out to analyse the steering functions. The mechanical analysis results in the identification of five limitations: (1) low torsion, (2) shaft shortening, (3) high unpredictable friction, (4) coupled tip-shaft movements, and (5) complex cardiac environment. Solutions are found to each of the limitations and result in the design of a novel multi-steerable catheter with four degrees of freedom. A prototype is developed which allows the dual-segmented tip to be steered over multiple planes and in multiple directions, allowing a range of complex motions including S-shaped curves and circular movements. A detailed analysis of limitations underlying mechanically steerable catheters has led to a new design for a multi-steerable catheter for complex cardiac interventions. The four integrated degrees of freedom provide a high variability of tip directions, and repetition of the bending angle is relatively simple and reliable. The ability to steer inside the heart with a variety of complex shaped curves may potentially change conventional approaches in interventional cardiology towards more patient-specific and lower complexity procedures. Future directions are headed towards further design optimizations and the experimental validation of the prototype.@en

With the ongoing miniaturization of surgical instruments, the ability to apply large forces on tissues for resection becomes challenging and the risk of buckling becomes more real. In an effort to allow for high force application in slender instruments, in this study, we have investigated using a hydraulic pressure wave (COMSOL model) and developed an innovative 5F cardiac catheter (L = 1,000 mm) that allows for applying high forces up to 9.0 ± 0.2 N on target tissues without buckling. The catheter uses high-speed pressure waves to transfer high-force impulses through a slender flexible shaft consisted of a flat wire coil, a double braid, and a nylon outer coating. The handle allows for single-handed operation of the catheter with easy adjusting of the input impulse characteristic, including frequency (1–10 Hz), time and number of strokes using a solenoid actuator, and easy connection of an off-the-shelf inflator for catheter filling. In a proof-of-principle experiment, we illustrated that the Wave catheter was able to penetrate a phantom model of a coronary Chronic Total Occlusion (CTO) manufactured out of hydroxyapatite and gelatin. It was found that the time until puncture decreased from 80 ± 5.4 s to 7.8 ± 0.4 s, for a stroke frequency of 1–10 Hz, respectively. The number of strikes until puncture was approximately constant at 80 ± 5.4, 76.7 ± 2.6, and 77.7 ± 3.9 for the different stroke frequencies. With the development of the Wave catheter, first steps have been made toward high force application through slender shafts.@en

Parts produced with metal additive manufacturing often suffer from a poor surface finish. Surface finishing techniques are effective to improve the quality of 3D printed surfaces, however they have as downsides that they also slightly change the geometry of the part, in an unpredictable way. This effect on the geometrical features of complex parts has received little attention. In this research, we illustrate a method to visualize the impact of surface finishing techniques on geometrical features, as well as their effectiveness on parts with high shape-complexity, by using centrifugal disk finishing as a case study. We designed and 3D printed test parts with different features using selective laser melting, which were coated with a blue metal lacquer prior to polishing. After polishing, the blue lacquer was eroded away from the spots that were easily reached by the polishing process, yet had remained on the surfaces that could not be reached by the process. We used measurements of material removal and image processing of the remaining blue lacquer on the surfaces to analyze these effects. Using this method, we were able to derive a number of specific design guidelines that can be incorporated while designing metal AM parts for centrifugal disk finishing. We suggest that this visualization method can be applied to different polishing methods to gain insight into their influence, as well as being used as an aid in the design process.@en

The fields of Minimally Invasive Surgery (MIS) and Natural Orifices Transluminal Endoscopic Surgery (NOTES) strive to reduce the level of invasiveness by entering the body through smaller incisions and natural orifices. Hyper-redundant snake-like instruments can help in this pursuit of reducing invasiveness. Such instruments can pass along multi-curved pathways through the body without any support or guidance from its anatomical environment. In this way, the width of the surgical pathway and thus the invasiveness of the procedure can be reduced significantly. This is referred to as Follow-the-Leader (FTL) motion. Generally, surgical instruments intended for FTL-motion are robotic systems that require medical grade actuators, sensors, and controllers, driving up costs and increasing their footprint in the operation room. Our goal was to discard the need for these elements and develop a non-robotic instrument capable of FTL-motion along pre-determined paths. A proof of concept prototype called MemoFlex II was developed, consisting of a cable-driven hyper-redundant shaft that is controlled via four physical tracks. The MemoFlex II was able to perform 3D FTL-motion along pre-determined paths. Among other things, this study reports on a Ø8 mm shaft containing seven segments and 14 degrees of freedom (DOFs) following several multi-curved paths with an average maximal footprint between 11.0 and 17.1 mm.@en

Metal additive manufacturing is a promising technology for the production of functional medical products, due to its high shape complexity and resolution, and ability to withstand sterilization temperatures. This study explores the possibility of designing a completely non-assembly steerable surgical instrument using Selective Laser Melting. Despite its advantages for medical devices, the rough surface quality of unfinished parts can be problematic for non-assembly designs, leading to increased friction and wear in rigid body mechanisms and tendon-actuated mechanisms. We investigated printing of rolling contact joints with crossed flexures as low-friction joints, adjusted for printing in titanium for the design of the instrument. Grid-based lattice structures were incorporated as miniature flexures, and we explored the influence of various grid sizes on the flexibility and bending stiffness of the lattices. Based on this exploration, we altered the rolling joint configuration from two crossed flexures to a single straight flexure for our design. The resulting steerable surgical instrument design is completely non-assembly, including its actuation, facilitates easy removal of support structures, and requires no surface finishing steps. It has a diameter of less than 20 mm, facilitates opening and closing of a grasper, and steering of the grasper by 20 degrees.@en

In laparoscopy, a small incision size improves the surgical outcome but increases at the same time the rigidity of the instrument, with consequent impairment of the surgeon’s maneuverability. Such reduction introduces new challenges, such as the loss of wrist articulation or the impossibility of overcoming obstacles. A possible approach is using multi-steerable cable-driven instruments fully mechanical actuated, which allow great maneuverability while keeping the wound small. In this work, we compared the usability of the two most promising cable configurations in 3D printed multi-steerable instruments: a parallel configuration with all cables running straight from the steerable shaft to the handle; and a multi configuration with straight cables in combination with helical cables. Twelve participants were divided into two groups and asked to orient the instrument shaft and randomly hit six targets following the instructions in a laparoscopic simulator. Each participant carried out four trials (two trials for each instrument) with 12 runs per trial. The average task performance time showed a significant decrease over the first trial for both configurations. The decrease was 48% for the parallel and 41% for the multi configuration. Improvement of task performance times reached a plateau in the second trial with both instruments. The participants filled out a TLX questionnaire after each trial. The questionnaire showed a lower burden score for the parallel compared to multi configuration (23% VS 30%). Even though the task performance time for both configurations was comparable, a final questionnaire showed that 10 out of 12 participants preferred the parallel configuration due to a more intuitive hand movement and the possibility of individually orienting the distal end of the steerable shaft@en

In minimally invasive surgery, maneuverability is usually limited and a large number of degrees of freedom (DOF) is highly demanded. However, increasing the DOF usually means increasing the complexity of the surgical instrument leading to long fabrication and assembly times. In this work, we propose the first fully 3D printed handheld, multi-steerable device. The proposed device is mechanically actuated, and possesses five serially controlled segments. We designed a new compliant segment providing high torsion and axial stiffness as well as a low bending stiffness by merging the functions of four helicoids and a continuum backbone. Compliant segments were combined to form the compliant shaft of the new device. In order to control this compliant shaft, a control handle was designed that mimics the shaft structure. A prototype called the HelicoFlex was built using only three 3D printed parts. HelicoFlex, with its 10 degrees of freedom, showed a fluid motion in performing single and multi-curved paths. The multi-steerable instrument was 3D printed without any support material in the compliant shaft itself. This work contributes to enlarge the body of knowledge regarding how additive manufacturing could be used in the production of multi-steerable surgical instruments for personalized medicine.@en